PharmEng Technology is currently seeking a Quality Assurance Associate-Compliance Specialist to join our team for projects in Ontario, Canada. The position is available immediately conditional of a successful interview.
This role will act as a diversified technical person who works within the Quality Systems to support Manufacturing with quality control of GMP documentation, change control and CAPAs.
Quality control and coordination of GMP documentation BPRs, SOPs, logbooks, etc.)
As per quality operating procedure for Batch Production Records (BPRs) review, logbook review and sterilization records review, in collaboration with quality manager, ensure requirements for documentation of manufacturing operations are met. This includes:
Review BPRs and Logbook documentation in real-time when applicable,
Coordination of corrections if any,
And progress tracking (BPR tracking file for BPR).
Update of SOPs and GMP Documents
Quality / Project management (Change Control & CAPA system)
Initiate and manage change control or CAPA requests affecting the department. This includes presenting change control to the change control board.
Collaborate with assessors from different functions within IO (quality, engineering departments) and outside IO (regulatory affairs) for evaluation of changes.
Ensure timely closure of change controls or CAPA, including following up on the actions under other departments’ responsibility.
Support Lead Investigators and manufacturing in establishing change controls approved for execution or CAPA in a very short timeframe to support closure of Quality Notifications.
Representative for Site Wide Initiatives/ Continuous Improvement projects related to Quality Systems, Processes and Procedures.
Perform and/or participate in GQD gap analysis for the Department.
Identify opportunities for process improvements, applying lean methodology
Technical Writing / Assist SMEs in authoring GMP documentation
Work with SMEs to draft or revise GMP documents (SOPs, SWIs, protocols, or reports)
Assist with document management in Quality eDoc system
Add tables, figures, photographs where required
Perform quality checks on documents (to comply with formatting requirements)
Follow-up on the review and approval process to expedite document approval when necessary
Point of contact for Record & System Office
Prepare performance weekly Metrics reports for the department.
This includes data consolidation and metrics analysis with associated remediation plan when needed for change control performance, CAPA performance, GMP documentation tracking tool and SOP management.
4-year bachelor’s degree in Science
Minimum 1-2 years of experience in GMP environment
Efficiently use company tools such as SAP, TrackWise, QeDoc, Excel etc. and the ability to adapt to new tools
Strong interpersonal and organization skills
Strong verbal and written communication skills.
Thank you for your consideration and application! We review all resumes and submissions, however, due to the sheer volume of requests that we receive, only successful candidates will be contacted.